NOM-059-SSA1-2015
Comply with the standard from the design stage, not after the audit.
We design and build the facilities required by NOM-059-SSA1-2015 for the manufacture of sterile medical devices. Technical documentation ready for COFEPRIS is included in every project.
Evaluate your compliance with NOM-059
ISO 5-7
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NOM-059
What does the NOM-059-SSA1-2015 require?
NOM-059-SSA1-2015 establishes Good Manufacturing Practices for establishments that manufacture sterile medical devices in Mexico. It is the standard that COFEPRIS reviews in every sanitary license audit and that determines whether your production process can operate legally.
Unlike other regulations, NOM-059 is specific in its infrastructure requirements: it defines which areas must be controlled environments, what ISO classification they must have, how personnel and materials must flow, and which parameters must be continuously monitored.
Complying with the standard is not just about installing an HVAC system—it is an engineering project that begins with the area design and ends with documented installation, operation, and performance (IQ/OQ/PQ) qualification.
Parameters required by NOM-059 for sterile areas
- Sterile filling
- Immediate support
- Preparation
- General support
- Ambiental monitoring
- Required grade
- ISO 5 (Grado A)
- ISO 7 (Grado B)
- ISO 7–8 (Grado C)
- ISO 8 (Grado D)
- Cont · NOM-059
- IQ / OQ / PQ
Infrastructure requirements
Lo que la norma exige en instalaciones.
Cada clasificación define el número máximo de partículas por metro cúbico. A mayor exigencia del proceso, menor tolerancia de contaminación — y mayor inversión en el sistema de control ambiental.
01 — Áreas controladas
Classified cleanrooms
The standard requires zones differentiated by ISO classification according to the criticality of the process. Each zone must be qualified and under continuous particle monitoring.
02 — HVAC Systems
Pressure control and filtration
Positive differential pressure between zones, terminal HEPA filtration in critical zones, temperature control (20–22°C) and relative humidity (30–65% RH) with continuous recording.
03 — Healthcare Architecture
Finishes and staff flow
Smooth, non-porous surfaces resistant to detergents and disinfectants. Personnel and material airlocks with interlocks. Unidirectional flow without crossing of clean and dirty materials.
04 — IQ/OQ/PQ rating
Validation protocols
Installation, Operation, and Performance Qualifications are required before starting production. Documentation of these protocols is the first thing COFEPRIS reviews during an audit.
05 — Environmental monitoring
Continuous and traceable recording
Particle, temperature, and humidity monitoring systems with electronic or paper recording. Data must be retained for the period defined by the standard and be available for auditing.
06 — Preventive maintenance
Documented program
HVAC system maintenance plan, periodic replacement of HEPA filters, and requalification of the area after each major intervention. All documentation must be available for COFEPRIS.
Classification by zone — NOM-059 / EU GMP
Each area of your plant has a specific classification
NOM-059 adopts the classification by Grades (A, B, C, D) aligned with EU GMP Annex 1, which in turn corresponds to ISO 14644 classifications. Understanding which grade applies to each area of your process is the first step of the project.
Grade A
A
Sterile filling area, caps and closures. Mandatory unidirectional laminar flow. The most critical area of the plant.
Grade B
B
Immediate environment of Zone A. Support for aseptic operations. Requires continuous monitoring of stationary and operational particles.
Grade C
C
Preparation of solutions, washing of components and less critical stages of the sterile manufacturing process.
Grade D
D
General support areas: washing of non-critical materials, sterile component storage, access changing rooms.
Why Clean Rooms Mexico
We know the regulation.
We know COFEPRIS.
Technical file included
Each project is delivered with the complete technical file: as-built drawings, IQ/OQ/PQ protocols, particle reports and HEPA filter certificates — what COFEPRIS requests on the first visit.
Design from the process
A/B/C/D zoning is not decided at a desk — it is defined based on your manufacturing process, the type of device, and the level of sterility required by the standard.
GMP Sanitary Architecture
Finishes, sanitary joints, interlock valves and unidirectional flow designed in accordance with EU GMP Annex 1 and NOM-059. No construction improvisation.
Rating IQ/OQ/PQ
We carry out the installation, operation, and performance qualification protocols. Documentation is provided in the format accepted by COFEPRIS for processing the health license.
Audit support
Our team can accompany you during the COFEPRIS visit to answer technical questions about the facilities and the environmental monitoring system.
Adaptations to existing facilities
If you already have an installation that doesn't fully comply, we perform a gap audit, identify what requires intervention, and implement the necessary adjustments without interrupting your production.
Completed projects
Clients currently operating under NOM-059
Frequently Asked Questions
The most common questions we get asked before starting a project.
Does NOM-059-SSA1-2015 apply to all medical devices?
No. NOM-059-SSA1-2015 applies specifically to establishments that manufacture sterile medical devices. Other COFEPRIS standards apply to non-sterile devices. During the technical evaluation, we will confirm whether your process falls within the scope of this standard.
What is the difference between NOM-059 and NOM-059-SSA1-2015?
NOM-059-SSA1-2015 is the current version that replaced the previous NOM-059-SSA1-2006. The 2015 version aligned infrastructure requirements with EU GMP Annex 1 and incorporated grades A/B/C/D, replacing the previous classifications. If your company was audited under the 2006 version, there may be discrepancies with the current standard.
Can I adapt my existing installation or do I have to build from scratch?
It depends on the current state of your facility. In many cases, it’s possible to upgrade: improve the HVAC system, replace non-sanitary finishes, add personnel airlocks, and adjust zoning. We conduct a gap analysis that tells you exactly what needs to be addressed and how much it would cost versus new construction.
What documents does COFEPRIS require related to the facilities?
COFEPRIS typically requires: as-built drawings of the classified area, IQ/OQ/PQ qualification report, HEPA filter certificates, environmental monitoring results (particles, temperature, humidity), and the preventive maintenance program. All of this is included in the project we deliver.
How long does a NOM-059 compliance project take?
A retrofit of an existing installation can take between 10 and 20 weeks. A new project from scratch takes between 16 and 30 weeks, depending on the complexity. The most variable factor is qualification: if the systems fail the initial qualification (OQ), they must be corrected and retested, which can extend the timeframe by an additional 4–8 weeks.
Next Step
Does your facility comply with the NOM-059-SSA1-2015?
We conduct a free gap audit to identify which areas of your plant meet the standard and what requires intervention before your next COFEPRIS visit.